Study of Blood and Urine Samples in Patients With Newly Diagnosed Localized Prostate Cancer Treated With Hormone Therapy and Radiation Therapy
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Purpose
RATIONALE: Studying samples of blood and urine from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.
PURPOSE: This clinical trial is studying blood and urine samples in patients with newly diagnosed localized prostate cancer treated with hormone therapy and radiation therapy.
| Condition | Intervention |
|---|---|
|
Prostate Cancer |
Drug: bicalutamide Drug: releasing hormone agonist therapy Genetic: protein expression analysis Genetic: proteomic profiling Other: laboratory biomarker analysis Radiation: radiation therapy |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Proteomic Analysis of the Combined Hormonal Therapy and Radiation Therapy for Localized Prostate Cancer |
- Changes in serum and urine proteomic profiles [ Time Frame: Ongoing until patient progression ] [ Designated as safety issue: No ]
- Prognostic and biochemical markers of early disease progression [ Time Frame: Ongoing until patient progression ] [ Designated as safety issue: No ]
- Protein expression and temporal alterations [ Time Frame: Ongoing until patient progression ] [ Designated as safety issue: No ]
- Molecular targets [ Time Frame: Ongoing until patient progression ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 60 |
| Study Start Date: | September 2005 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- Detect changes in serum and urine proteomic profiles that predict outcome in patients with newly diagnosed localized prostate cancer treated with hormonal therapy and radiotherapy.
- Identify prognostic and biochemical markers of early disease progression in patients treated with this regimen.
- Identify unique protein expression and temporal alterations, in these profiles, that facilitate understanding of the factors predicting relapse or toxicity.
- Identify molecular signatures that allow identification of targets for therapeutic intervention.
OUTLINE: This is a multicenter study.
Patients receive induction hormones* (bicalutimide and releasing-hormone agonist) for approximately 4 months prior to starting radiotherapy. Patients then receive radiotherapy consisting of 74 Gy up to a maximum of 81 Gy to the prostate gland per standard treatment.NOTE: * Patients receiving short-term hormonal treatment for 4-8 months are eligible to participate in the trial.
Blood and urine samples are collected at baseline, and periodically during and after induction therapy for proteomic analysis.
After completion of study therapy, patients are followed up periodically for up to 3 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients diagnosed with localised prostate cancer who will receive radiation therapy plus hormonal therapy, for 4 - 8 months, are eligible for the trial. Patients will be eligible to participate in the trial provided they have not received prior therapy for their prostate cancer. It is planned that 60 patients will participate in the research study. All patients will receive approx 4 months of induction hormone therapy (LHRH agonist and Bicalutamide) prior to starting radiotherapy treatment.
Inclusion criteria:
- Age 18 years or over.
- Histologically confirmed invasive adenocarcinoma of the prostate (by TURP or TRUS).
- Localised prostate cancer with a Gleason score 7
- Short term hormonal treatment 4-8 months
- Performance status of KPS ≥ 60 / WHO 0-2
- Absence of distant metastases
Exclusion criteria:
- The patient has previously received treatment for prostate cancer other than TURP/ TRUS
- The patient has had a bilateral orchidectomy
- The patient has previously received hormonal treatment for prostate cancer
- Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the trial. In the opinion of the investigator, any evidence of severe or uncontrolled systematic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease
- The patient has or had other co-existing malignancies within the past 5 years other than non- melanoma skin cancer
- Treatment with non-approved or investigational drug within 30 days before day one of the trial
Contacts and Locations| Ireland | |
| Saint Luke's Radiation Oncology Network | |
| Dublin, Ireland, 6 | |
| UPMC Beacon Hospital | |
| Dublin, Ireland, 18 | |
| Principal Investigator: | John Gerard Armstrong, MD, MB, MRCPI | Saint Luke's Hospital |
More Information
Additional Information:
No publications provided
| Responsible Party: | ICORG- All Ireland Cooperative Oncology Research Group |
| ClinicalTrials.gov Identifier: | NCT00955435 History of Changes |
| Other Study ID Numbers: | CDR0000639281, ICORG-06-15, EU-20921 |
| Study First Received: | August 7, 2009 |
| Last Updated: | October 25, 2012 |
| Health Authority: | Ireland: Health Information and Quality Authority |
Keywords provided by ICORG- All Ireland Cooperative Oncology Research Group:
|
adenocarcinoma of the prostate stage I prostate cancer stage IIB prostate cancer stage IIA prostate cancer stage III prostate cancer |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Prostatic Diseases Hormones |
Bicalutamide Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Androgen Antagonists Hormone Antagonists Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 22, 2013